Weight Loss Update: FDA Panel Recommends Making Lap-Band Surgery Available to 12 Million More People

The procedure may help more people shed the pounds. But it will also fill the coffers of surgeons, hospitals, and a global specialty pharmaceutical company.

About 100,000 people each year have laparoscopic surgery to implant a small, flexible band—the Lap-Band, from Allergan, Inc.—on their stomach. It’s designed to help them lose weight by dramatically limiting their food intake.

The Lap-Band was developed as an alternative to gastric bypass surgery, a permanent procedure in which food is rerouted from a pouch in the stomach to the small intestine.

Experts stress that the Lap-Band cannot stop deeply ingrained behavior that drives people to overeat. Risks of gastric banding include ulceration, gastritis, difficulty swallowing, dehydration, constipation, weight regain, and death. The band can leak or slip, the stomach can slip or become blocked, and the band can erode into the stomach.

And it is an expensive procedure, which can range from $14,000 to $20,000. The device itself costs $3,000. And insurers are often reluctant to pay—which is why doubling the pool of potential patients is such a boon to the pharmaceutical company that makes it.

Another FDA advisory panel recommended the approval of a weight-loss drug called Contrave. The panel said the benefits of the diet pill outweigh the dangers of elevated pulse and blood pressure. They also said a large study on the cardiovascular risk of the drug can wait until after the drug is approved.

Wait. They’re going to approve a drug and then see if it’s harmful?

Contrave is a combination of two already-approved drugs that target different parts of the brain which influence appetite and cravings. The pill contains bupropion, an antidepressant also used to quit smoking, and naltrexone, a treatment for alcohol and painkiller addiction.

Note that many studies show the addictive qualities of conventional antidepressant drugs. So, under cover of providing a weight loss pill, millions of people may end up being hooked on an antidepressant.

The FDA had two stated standards of effectiveness for any weight loss drug it reviews. It is supposed to help patients lose at least 5% of their weight over 56 weeks (for a 300 pound man, that’s only a 15 pound loss in the course of more than a year), and it is supposed to show at least a 5% benefit over a placebo. Contrave met the first standard, and failed the second. The panel is recommending its approval anyway.

This comes on the heels of drug giant GlaxoSmithKlein petitioning the FDA to stop supplement producers from making any weight loss claims at all about their products. If the petition is approved, only FDA-approved drugs would be able to make weight loss claims. If Contrave is approved, as now seems likely, it may well lead the FDA to say yes to the Glaxo petition. Up to now, the FDA has been held back by the fact that so many weight loss drugs have been proved to be dangerous and failed to make it through the approval process.

You may wish to review our Action Alert on the subject from October (which among other things discusses the awful side effects of the Glaxo product). If you have not already done so, please send your message to the FDA. Tell them not to allow pharmaceutical companies to use the Citizen Petition process for their own financial gain.

Instead of paying for lapband surgeries, how about treating the real problem. Pay for psychiatric help or help remake our food supply to be more healthy? If lapband surgery helps people lose weight it proves that the problem is not phsiological but the inability or the lack of desire to change eating habits.

Marian Fricano

This is a ridiculous idea of entitling more obese people to get stomach bands.

Stomach bands only work initially. Long term they simply do not work as I have seen personally. I know 3 people who have had this surgery and only 1 has kept her weight down, but not as much as it was originally. The other two have gained back all of their original weight to the tune of each of them weighing over 200 pounds.

What is severely needed is more control of the food industry that laces everything fattening with chemicals to make it taste better than it should.

Marilyn

Absolutely ignorant thinking on lap-bound surgery. What doesn’t go in doesn’t go on. All of this hype and FDA doesn’t seem to know their business about weight loss. If a person is intent on losing pounds, he/she will find a healthy way to do it without the FDA. And, we sure don’t need Congress to take on obesity. They have more important things to do. If a woman doesn’t fit into her size 12 or 14 jeans any more, isn’t that a sign to lose some weight the normal way? If a man reaches the last notch in his belt, isn’t that some kind of clue that obesity is looking back from the mirror? Get our butts off the computer chair, start exercising. Eat to live and not Live to eat.

Barbara Talbert

This is a mis-guided attempt to solve the problem of obesity. Digestion is the problem and foods are not being digested properly and this is due to GMO’s in the food chain. Now they want it to be in animal feed so the insanity can continue. Surgery is advocated over healthy eating and the FDA is promoting it? If it wasn’t true it would seem ridiculous.

Kristine

I can’t believe that people support this type of surgery. It doesn’t address the root problem of obesity, poor diets, bad eating habits and/or lack of exercise. It seems like it should be the very last option after many other things have been tried. Even then I’m not sure if it’s a good idea.

And here we go again! Exactly WHO needs lap-band surgery, after which they will live short and unhealthy lives before an early death. I worked in healthcare for 30 years, and this is the kind of thing I saw far too often. If the FDA were doing its job to insist on HEALTHY FOOD so that people were eating the vitamins, minerals, antioxidants, and enzymes they need in CLEAN food instead of thinking about lap-band surgery for the failure to insist on healthy foods, not the pretense found on our grocery shelves today, you would never have such a foolish thought pass through a single citizen’s head.

It wouldn’t hurt to teach nutrition, by which I don’t mean the version the FDA would present.

Don Newsom

The FDA is a bunch of greedy bastards just wanting money or “sales” if you will. They don’t care how many die from there dangerous drugs. It’s follow the money. We need to educate our society not to trust regular doc’s and of course learn about alternative medicine. Regular doc’s are good at finding problems with there many test or fixing you up after a bad accident or some flash of the second thing that happens to us.Long term care—forget the Md’s and DO’s.

MonteK

You know what how about teaching Doctors to practice prevention? How about all these food companies quit puttting out crap food? There are more obese people now than ever and guess whose benefiting from this? Big Corps raking in billions of the crap food they make. Doctors treating patients that are obese by using lap-bands etc. When’s the last time you heard a Doctor tell you to loose weight? Preventive care should be rewarded in this Country not discouraged.

How about just outlawing high fructose corn syrup, or would that just be too simple??

Robin Stump

Please do not allow pharmaceutical companies to use the Citizen Petition process for their own financial gain. These companies never have the improved welfare of humans as a priority, their only focus is financial gain. And if a few hundred or thousand peple are hurt, or die, they still made money. Pulling a product AFTER it has caused harm is not a sane method of keeping the public safe.

Donna J

What is wrong with people? Can’t they think for themselves? This is an illogical approach to their problem and will forever change their bodies. Stop eating junk and move your body.

Robert Morrow

Lap bands are just another rip off promoted by the Pharmaceutical, FDA, FTC, AMA to increase Profits. In order to reduce the obese in the nation, one must first Stop the FDA in approval of poison drugs which kill over 200,000 per year. Next stop the 15.000 toxic material from being added to the processed food which cause people to be fat, high blood pressure and on and on. Ask yourself why are the lap bands being promoted? Only to increase the Profits of the AMA Doctors, the Pharmaceutical and food processors. Remember it is all about the money (Profits). At this point I will insert a Quote from Hebert Ley, M.D. Former FDA Commissioner. Quote:” THE THING THAT BUGS ME IS THAT PEOPLE THINK THE FDA IS PROTECTING THEM. IT ISN’T. THE FDA IS PROTECTING THE PROFITS OF THE CORPORATIONS THAT PAY US AND THE POLITICIANS!”. end of quote. Lets take a little journey into the corruption of the FDA, FTC, Pharmaceutical and your own corrupt elected official. Take the drug Vioxx a pain killer which was no better than any over the counter drug, but cost was outrageously more expensive. Plus it produced profits in the millions and all OK by the FDA, FTC. This Vioxx was kept on the market in spite of 100,000 deaths or until the Pharmaceutical gained enough profit to pay off the FDA, FTC and your congressman. Do they care? No way as it is all about the Profit and never mind the blood that is on their hands. Again, why are people fat? Four things, one the toxins in your body from the poison food and drugs. two these cause your immune system to be weaken, then you becomes sick and go to the AMA Drug pushing Doctors, Three, more drugs and you become fatter, and sicker. once that they get all your money you would be allow to die. I know this as I have been obese, ill and seen the drug pushers. I finely woke up and studied and read about the subject. Now I take no poison drugs of any kind, Reduced my weight by 65 pounds, waist from 46 inches to less than 40 inches, blood pressure less than 120/68. very high energy levels, and only 82 years young. I teach free ” how to cook at home for health.” plus how the Pharmaceutical, FDA, FTC and your AMA drug pushing doctor make you sick. One more thing look at just who advocated the lap bands. FDA Panels, that should tell you the truth.

I strongly encourage that we quite putting band aide solutions on the issues.we face in this Country. my experience with Doctors is that Doctors can only drug it out or cut it out. When it comes to these types of lifestyle issues only we can change our minds the ACE study on obesity shows there is more going on with the mental health of individuals who are over weight and underweight.

Raiine

A co-worker beloved by all, never left the hospital after lapband surgery. She died because of some toxic stuff in her intestines that they couldn’t get out, I think because of the lapband. I’m willing to bet it’s not that uncommon.

Rich

It seems a little narrow-minded and foolish to generalize lap-band (or any other treatment) as “evil” or unnecessary for people in general. The reality is, each person’s physiology, genetics, habits, predisposition to certain risks, and environment are different and unique. Therefore, the only person who reserves the right to judge an individual patient’s needs is, besides the patient, that patient’s primary care manager/physician.

I only say the letters “Dr.” in front of one person’s name among all of these comments. If someone wants to speculate about the “real fix to society’s medical challenges”, go earn your doctorate… do some legitimate research of your own. Until then, an individual’s specific needs are between that person and the doctor who they have built a trusting professional relationship with.